56836 Federal Register / Vol. 88, No. 160 / Monday, August 21, 2023 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hr) 

Total burden 

(in hr) 

Aim 1 participants—YMSM; General 

public, adults.

Aim 1 Participant Follow-up Survey 134 4 30/60 268 

Aim 2 participants—YMSM; General 

public, adults.

Aim 2 Participant Eligibility Screener 20 1 5/60 2 

Aim 2 participants—YMSM; General 

public, adults.

Aim 2 Participant Locator Form ....... 10 1 5/60 1 

Aim 2 participants—YMSM; General 

public, adults.

Aim 2 Participant Interview Guide ... 10 1 1.0 10 

Aim 3 participants—providers; General public, adults.Aim 3 Participant Eligibility Screener 14 1 5/60 2 

Aim 3 participants—providers; General public, adults.Aim 3 Participant Locator Form ....... 7 1 5/60 1 

Aim 3 participants—providers; General public, adults.Aim 3 Participant Interview Guide ... 7 1 1.0 7 

Aim 3 participant—clinic staff respondent, 1 per clinic site; General public, adults.Aim 3 Clinic Assessment ................. 4 2 30/60 4 

Total ........................................... ........................................................... ........................ ........................ ........................ 441 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2023–17921 Filed 8–18–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–23–1319; Docket No. CDC–2023– 

0073] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies the opportunity to comment on 

a continuing information collection, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on a proposed information 

collection project titled National 

Surveillance of Community Water 

Systems and Corresponding Populations 

with the Recommended Fluoridation 

Level. This surveillance collects the 

fluoridation status of, and population 

served by the nation’s 52,000 

community water systems (CWS) which 

serve the 50 States and the District of 

Columbia. 

DATES: CDC must receive written 

comments on or before October 20, 

2023. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2023– 

0073 by either of the following methods: 

• Federal eRulemaking Portal: 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS H21–8, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

www.regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(www.regulations.gov) or by U.S. mail to 

the address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Jeffrey M. Zirger, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, MS 

H21–8, Atlanta, Georgia 30329; 

Telephone: 404–639–7570; Email: omb@

cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The OMB is particularly interested in 

comments that will help: 

1. Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses; and 

5. Assess information collection costs. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 160 / Monday, August 21, 2023 / Notices 56837 

1Section 503B(a) of the FD&C Act. 

2Compare section 503A(a) of the FD&C Act (21 

U.S.C. 353a(a) (exempting drugs compounded in 

accordance with that section)) with section 503B(a) 

of the FD&C Act (not providing an exemption from 

CGMP requirements). 3Section 503B(b)(4) and (5) of the FD&C Act. 

Proposed Project 

National Surveillance of Community 

Water Systems and Corresponding 

Populations with the Recommended 

Fluoridation Level (OMB Control No. 

0920–1319, Exp. 2/29/2024)— 

Extension—National Center for Chronic 

Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

Community water fluoridation is the 

process of adjusting the fluoride 

concentration of a community water 

system (CWS) to the level beneficial for 

prevention of dental caries as 

recommended by the U.S. Public Health 

Service (PHS). Community water 

fluoridation is a major factor 

contributing to the large decline in 

caries in the U.S. in the past 75 years 

and is recognized as one of 10 great 

public health achievements of the 

twentieth century. Community water 

fluoridation reduces dental caries by 

25% and is a safe and the cost-effective 

way to deliver fluoride to people of all 

ages, regardless of education and 

income level. It is especially important 

for populations with limited access to 

preventive dental measures. 

CDC is authorized to collect the 

information under the U.S. Public 

Health Service Act. This data collection 

aligns with CDC’s strategy to use public 

health surveillance to inform programs 

and policies to improve the oral health 

of the nation by reducing disparities and 

expanding access to effective prevention 

programs. CDC uses the Water 

Fluoridation Reporting System (WFRS) 

to collect water fluoridation coverage 

and quality throughout the U.S. This 

data allows CDC and States to monitor 

the performance and efficiency of their 

water fluoridation programs, which will 

improve and extend program delivery. 

Respondents to the information 

collection are State fluoridation 

managers or other State government 

officials designated by the State dental 

director or drinking water administrator. 

State participation in the data collection 

is voluntary. 

CDC requests OMB approval for an 

estimated 2,824 annual burden hours. 

There is no cost to respondents other 

than their time to participate. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

State Official ...................................... Fluoridation status and population ... 50 1 38 1,900 

State Official ...................................... Fluoride testing data ........................ 33 1 28 924 

Total ........................................... ........................................................... ........................ ........................ ........................ 2,824 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2023–17925 Filed 8–18–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3240] 

List of Bulk Drug Substances for 

Which There is a Clinical Need Under 

Section 503B of the Federal Food, 

Drug, and Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is evaluating substances that have 

been nominated for inclusion on a list 

of bulk drug substances (active 

pharmaceutical ingredients) for which 

there is a clinical need (the 503B Bulks 

List). Drug products that outsourcing 

facilities compound using bulk drug 

substances on the 503B Bulks List can 

qualify for certain exemptions from the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) provided certain conditions 

are met. This notice identifies two bulk 

drug substances that FDA has 

considered and is not including on the 

list at this time: ephedrine sulfate and 

hydroxychloroquine sulfate. Additional 

bulk drug substances nominated by the 

public for inclusion on this list are 

currently under consideration and will 

be the subject of future notices. 

DATES: The announcement of the notice 

is published in the Federal Register on 

August 21, 2023. 

ADDRESSES: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts, 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Tracy Rupp, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Silver Spring, MD 20993, 

301–796–3100. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 503B of the FD&C Act (21 

U.S.C. 353b) describes the conditions 

that must be satisfied for drug products 

compounded in an outsourcing facility 

to be exempt from section 505 (21 

U.S.C. 355) (concerning the approval of 

drugs under new drug applications 

(NDAs) or abbreviated new drug 

applications (ANDAs)), section 502(f)(1) 

(21 U.S.C. 352(f)(1)) (concerning the 

labeling of drugs with adequate 

directions for use), and section 582 of 

the FD&C Act (21 U.S.C. 360eee–1) 

(concerning drug supply chain security 

requirements).1

Compounded drug products that meet 

the conditions set forth in section 503B 

are not exempt from current good 

manufacturing practice (CGMP) 

requirements in section 501(a)(2)(B) of 

the FD&C Act (21 U.S.C. 351(a)(2)(B)).2

Outsourcing facilities are also subject to 

FDA inspections according to a riskbased schedule, adverse event reporting 

requirements, and other conditions that 

help to mitigate the risks of the drug 

products they compound.3 Outsourcing 

facilities may or may not obtain 

prescriptions for identified individual 

patients and can, therefore, distribute 

compounded drugs to healthcare 


ddrumheller on DSK120RN23PROD with NOTICES1